H3, h6: the navio thumbscrew p/n 100026 intended for use in treatment was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.While all products meet required manufacturing specifications prior to release a serial number, lot number, or part revision is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirm, factors that may have contributed to the reported symptom may have been associated with over tightening with excessive force by the user.Per the navio surgical system user's manual "to close and lock the clamshell, it is recommended to twist the thumbscrew by hand clockwise, until it is tightened securely." to attach the handpiece tracker, twist the thumbscrews clockwise by hand and then use the t-handle wrench to tighten the thumbscrews until the handpiece tracker array is firmly attached to the handpiece.Note: do not overtighten the thumbscrews." although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
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